Revealed: recommendations from the Accelerated Access Review
pharmafile | October 27, 2015 | News story | Manufacturing and Production, Research and Development | Accelarated Access Review, NHS
Ministers have been urged to introduce conditional approvals for innovative new drugs, and ‘radically new’ central agreements on drug pricing, as part of a raft of changes to dramatically ramp up access to new health technologies developed by the pharma industry.
In a leaked copy of the interim report from the Government’s long-anticipated Accelerated Access Review (AAR), the review panel calls for ‘a radically new approach’ to enable emerging products into the health service. It also calls for a “fundamental shift to a much more proactive approach… if we are to meet the challenge of delivering earlier patient access, at a cost the system can afford.”
The interim report, seen by Pharmafile, includes suggestions for steps to take towards the new approach. It finds it will require measures including conditional approvals from NICE, and agreements between companies and the health system to take on access and control financial risk – with subsequent decisions based on cost, the performance of the drug, or a combination of the two.
It also suggests that the agreements would be supported by new and ‘more flexible’ approaches to reimbursement. These could include simple discounts, but also more complex schemes such as price-volume agreements, multi-year agreements conditional on companies achieving agreed outcomes, patient cost caps, or free or discounted treatment initiation. These agreements could be negotiated directly by the NHS, or even by NICE, instead of the current pricing deals struck with the Department of Health.
“Such a system, carefully managed, offers the best prospect for our NHS of achieving timely patient access to the most promising new products, while ensuring that growth in healthcare budgets is sustainable,” the report states.
The suggestions also include expanding existing initiatives that offer earlier market access, such as the MHRA’s Early Access to Medicines Scheme and the EMA’s conditional approval and adaptive pathways pilots. It also includes the possible development of a status for drugs to recognise a ‘new designation showing promise’. This would be similar to the FDA’s Breakthrough Therapy designation, which has now been applied to more than 40 new drugs in the US. A similar designation is under consideration across Europe by the EMA.
In his summary letter to Life Sciences Minister George Freeman, AAR chair Sir Hugh Taylor warns: “We have the potential to build upon our thriving life sciences industry, through which our economy as well as our patients will benefit.
“But we will lose ground if research budgets are threatened, if our leading academic hospitals cannot afford to support research or use the latest drugs and technologies to pioneer developments in the treatment of the most complex conditions, or if the wider system is paralysed by the cost pressures it is facing and fails to invest in the change and innovation it requires to deliver better care to patients more efficiently and productively.”
This, he says, will require:
- A commitment to working with companies at a much earlier stage of development, on bespoke packages for licensing, evaluation and reimbursement, and then at every stage of the innovation pathway, supporting them to deliver these products to our health system at the earliest possible opportunity
- Enhanced provision in the system for commercial access agreements, linking assessment and budgetary control – with the aim of managing the entry of a product to the system as early as possible in the product cycle, when the evidence to determine its longer-term value has not been fully established
- A possible mechanism for submitting drugs with a ‘new designation showing promise’ to NICE for rapid appraisal on a new accelerated pathway
- Further improvements in timescales for access to patient trials and a greater emphasis on evaluation through commissioning, along with exploring new trial methodologies to accelerate evidence generation and “take the cost out of the process”. This would include greater use of anonymised real-time patient data gathered through the NHS.
Sir Hugh says the volume and strength of the responses to the AAR’s call for responses shows there is a ‘collective will’ to solve the challenges currently facing the health system.
And Professor Sir John Bell, chair of the review’s external advisory group, warns: “A failure to anticipate the challenge and manage it with new pathways for rapid adoption and diffusion of innovation could, in the longer-term, be damaging to the NHS and its patients.
He adds: “In order to handle this new wave of innovation in the context of a dramatic shift in the way we define disease and target interventions, the NHS will need a new approach to the whole pathway of regulation, evaluation and adoption. Without a new approach, it is likely that the NHS will find it increasingly challenging to deliver innovation in a timely way to the population and that it will struggle to maintain the balance between the cost of innovation and the need to provide patients with novel approaches to deliver improved care.”
A third of the responses to the review’s 18 questions, which were posed during a three-month open engagement process, came from the pharma industry. The wide-ranging review gathered nearly 400 responses and suggestions, which were compiled by an independent organisation and distilled into ‘key themes’, on which the interim report is based. This second phase of the review will be a consultation to seek feedback on specific suggestions made in the interim report, before a full report and recommendations are published in the Spring.
Lilian Anekwe
Related Content
A community-first future: which pathways will get us there?
In the final Gateway to Local Adoption article of 2025, Visions4Health caught up with Julian …
The Pharma Files: with Dr Ewen Cameron, Chief Executive of West Suffolk NHS Foundation Trust
Pharmafile chats with Dr Ewen Cameron, Chief Executive of West Suffolk NHS Foundation Trust, about …
Is this an Oppenheimer moment for the life sciences industry?
By Sabina Syed, Managing Director at Visions4Health In the history of science, few initiatives demonstrate …
